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alli and SHUTTLE are registered trade marks of the GSK group of companies. The SHUTTLE carry case is a trade mark of the GSK group of companies.

www.alli.co.uk www.alli.ie

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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

You must talk to your doctor or pharmacist if you do not lose weight after taking alli for 12 weeks. You may need to stop taking alli.

What is in this leaflet:1. What alli is and what it is used for

■ Risk of being overweight

■ How alli works

2. What you need to know before you take alli

■ Do not take alli

■ Warnings and precautions

■ Other medicines and alli

■ alli with food and drink

■ Pregnancy and breast-feeding

■ Driving and using machines

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3. How to take alli

■ Preparing to lose weight

| Choose your start date

| Decide on your weight loss goal

| Set your calorie and fat targets

■ Taking alli

| Adults 18 and over

| How long should I take alli for?

| If you take more alli than you should

| If you forget to take alli

4. Possible side effects

■ Serious side effects

■ Very common side effects

■ Common side effects

■ Effects seen in blood tests

■ Learn to deal with diet-related treatment effects

5. How to store alli

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6. Contents of the pack and other information

■ What alli contains

■ What alli looks like and contents of the pack

■ Marketing authorisation holder and manufacturer

■ Further helpful information

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What alli is and what it is used for

This chapter contains:

■ Risk of being overweight

■ How alli works

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What alli is and what it is used for alli is used for weight loss in adults aged 18 and over who are overweight, and have a body mass index (BMI) of 28 or above. alli should be used along with a reduced calorie, lower-fat diet.

BMI is a way to find out if you have a healthy weight, or are overweight, for your height. The chart below will help you find out whether you are overweight and whether alli is right for you.

Find your height on the chart. If you weigh less than the weight shown for your height, do not take alli.

Height

1.50 m

1.55 m

1.60 m

1.65 m

1.70 m

1.75 m

1.80 m

1.85 m

1.90 m

Weight

63 kg

67.25 kg

71.75 kg

76.25 kg

81 kg

85.75 kg

90.75 kg

95.75 kg

101 kg

Height

4’ 10’’

5’ 0’’

5’ 2’’

5’ 4’’

5’ 6’’

5’ 8’’

5’ 10’’

6’ 0’’

6’ 2’’

Weight

9 st 8 lbs

10 st 3 lbs

10 st 13 lbs

11 st 9 lbs

12 st 5 lbs

13 st 2 lbs

13 st 13 lbs

14 st 10 lbs

15 st 8 lbs

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2What you need to know before you take alli

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What you need to know before you take alli

This chapter contains:

■ Do not take alli

■ Warnings and precautions

■ Other medicines and alli

■ alli with food and drink

■ Pregnancy and breast-feeding

■ Driving and using machines

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What you need to know before you take alliX Do not take alli

■ If you are allergic to orlistat or any of the ingredients of this medicine (listed in section 6).

■ If you are pregnant or breast-feeding.

■ If you are taking ciclosporin, used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions.

■ If you are taking warfarin or other medicines used to thin the blood.

■ If you have cholestasis (condition where the flow of bile from the liver is blocked).

■ If you have problems absorbing food (chronic malabsorption syndrome) diagnosed by a doctor.

! Warnings and precautions

Talk to your doctor or pharmacist before taking alli

■ If you have diabetes. Tell your doctor who may need to adjust your anti-diabetic medicine.

■ If you have kidney disease. Talk to your doctor before taking alli if you have problems with your kidneys. The use of orlistat may be associated with kidney stones in patients suffering from chronic kidney disease.

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! Children and adolescentsThis medicine must not be taken by children and adolescents under 18 years old.

! Other medicines and allialli may affect some medicines you have to take.

➜ Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Do not take alli with these medicines

■ Ciclosporin: ciclosporin is used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions.

■ Warfarin or other medicines used to thin the blood.The oral contraceptive pill and alli

■ The oral contraceptive pill may be less effective if you get severe diarrhoea. Use an extra method of contraception if you get severe diarrhoea.Take a multivitamin everyday if you are taking alli.

■ alli can lower the levels of some vitamins absorbed by your body. The multivitamins should contain vitamins A, D, E and K. You should take the multivitamin at bedtime, when you will not be taking alli, to help ensure that the vitamins are absorbed.

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Talk to your doctor before taking alli if you are taking ■ amiodarone, used for heart rhythm problems. ■ acarbose (an anti-diabetic drug used to treat type 2 diabetes

mellitus). alli is not recommended for people taking acarbose. ■ a thyroid medicine (levothyroxine) as it may be necessary to adjust

your dose and take your medicines at different times of the day. ■ a medicine for epilepsy as any changes in the frequency and

severity of your convulsions should be discussed with your doctor. ■ medicines to treat HIV. It is important that you consult your doctor

before taking alli if you are receiving treatment for HIV. ■ medicines for depression, psychiatric disorders or anxiousness.

Talk to your doctor or pharmacist when taking alli ■ If you are taking a medicine for high blood pressure as it may be

necessary to adjust your dose. ■ If you are taking a medicine for high cholesterol as it may be

necessary to adjust your dose.

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alli with food and drinkalli should be used along with a reduced calorie, lower-fat diet. Try to start this diet before beginning treatment. For information on how to set your calorie and fat targets, see Further helpful information in the blue pages in section 6.

alli can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water. This usually means one capsule at breakfast, lunch and dinner. If you miss a meal, or your meal contains no fat, do not take a capsule. alli does not work unless there is some fat in the meal.

If you eat a high-fat meal, do not take more than the recommended dose. Taking the capsule with a meal containing too much fat may increase your chance of getting diet-related treatment effects (see section 4). Make every effort to avoid any high-fat meals while taking alli.

X Pregnancy and breast-feedingDo not take alli if you are pregnant or breast-feeding.

Driving and using machinesalli is unlikely to affect your ability to drive and use machines.

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3How to take alli

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How to take alli

This chapter contains: ■ Preparing to lose weight

| Choose your start date

| Decide on your weight loss goal

| Set your calorie and fat targets

■ Taking alli

| Adults 18 and over

| How long should I take alli for?

| If you take more alli than you should

| If you forget to take alli

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How to take alli

Preparing to lose weight1. Choose your start date Choose the day you will start taking the capsules ahead of time. Before you start taking the capsules, begin your reduced calorie, lower-fat diet and give your body a few days to adjust to your new eating habits. Keep a record of what you are eating in a food diary. Food diaries are effective, because they make you aware of what you are eating, how much you eat, and give you the basis to make changes.

2. Decide on your weight loss goalThink about how much weight you want to lose and then set a target weight. A realistic goal is to lose between 5% to 10% of your starting weight. The amount of weight you lose may vary from week to week. You should aim to lose weight at a gradual, steady pace of about 0.5 kg (1 lb) per week.

3. Set your calorie and fat targetsTo help you reach your weight-loss goal you need to set two daily targets, one for calories and one for fat. For further advice see Further helpful information in the blue pages in section 6.

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Taking alliAdults 18 and over

■ Take one capsule, three times a day.

■ Take alli just before, during or up to one hour after meals. This usually means one capsule at breakfast, lunch and dinner. Make sure your three main meals are well balanced, reduced calorie, and lower-fat.

■ If you miss a meal, or your meal contains no fat, do not take a capsule. alli does not work unless there is some fat in the meal.

■ Swallow the capsule whole with water.

■ Do not take more than 3 capsules a day.

■ You can keep your daily dose of alli in the blue carry case (Shuttle®)included in this pack.

■ Eat lower-fat meals to reduce the chance of diet-related treatment effects (see section 4).

■ Try to be more physically active before you start taking the capsules. Physical activity is an important part of a weight loss programme. Remember to check with your doctor first if you have not exercised before.

■ Continue to be active while taking alli and after you stop taking it.

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How long should I take alli for? ■ alli should not be taken for more than six months.

■ If you do not lose weight after taking alli for 12 weeks, see your doctor or pharmacist for advice. You may need to stop taking alli.

■ Successful weight loss is not just about eating differently for a short period of time before reverting to your old habits. People who lose weight and maintain the loss make lifestyle changes, which include changes to what they eat and how active they are.

If you take more alli than you should ■ Do not take more than 3 capsules a day.

➜ If you have taken too many capsules, contact a doctor as soon as possible

If you forget to take alli

If you miss taking a capsule:

■ If it is less than an hour since your last main meal, take the missed capsule.

■ If it is more than an hour since your last main meal, do not take the missed capsule. Wait and take the next capsule around your next main meal as usual.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4Possible side effects

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Possible side effects

This chapter contains:

■ Serious side effects

■ Very common side effects

■ Common side effects

■ Effects seen in blood tests

■ Learn to deal with diet-related treatment effects

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Possible side effectsLike all medicines, this medicine can cause side effects, although not everybody gets them. Most of the common side effects related to alli (for example, wind with or without oily spotting, sudden or more frequent bowel motions and soft stools) are caused by the way it works (see section 1). Eat lower-fat meals to help manage these diet-related treatment effects.

Serious side effects It is not known how frequently these side effects occur.

! Severe allergic reactions ■ Signs of a severe allergic reaction include: severe breathing difficulties,

sweating, rash, itching, swollen face, rapid heart beat, collapse.

➜ Stop taking the capsules. Get medical help immediately.

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! Other serious side effects ■ Bleeding from the back passage (rectum).

■ Diverticulitis (inflammation of the large intestine). Symptoms may include lower stomach (abdominal) pain, particularly on the left side, possibly with fever and constipation.

■ Pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain sometimes radiating towards the back, possibly with fever, nausea and vomiting.

■ Skin blistering (including blisters that burst).

■ Severe stomach pain caused by gallstones.

■ Hepatitis (inflammation of the liver). Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.

■ Oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones). See section 2, warnings and precautions.

➜ Stop taking the capsules. Tell your doctor if you get any of these.

Very common side effects These may affect more than 1 in 10 people taking alli

■ Wind (flatulence), with or without oily spotting.

■ Sudden bowel motions.

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■ Fatty or oily stools.

■ Soft stools.

➜ Tell your doctor or pharmacist if any of these side effects gets severe or troublesome

Common side effects

These may affect up to 1 in 10 people taking alli

■ Stomach (abdominal) pain.

■ Incontinence (stools).

■ Runny/liquid stools.

■ More frequent bowel motions.

■ Anxiety.

➜ Tell your doctor or pharmacist if any of these side effects gets severe or troublesome

Effects seen in blood tests

It is not known how frequently these effects occur

■ Increases in the levels of some liver enzymes.

■ Effects on blood clotting in people taking warfarin or other blood-thinning (anti-coagulant) medicines.

➜ Tell your doctor that you are taking alli when you have a blood test

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If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Learn to deal with alli effects related to your diet or fat intake

The most common side effects are caused by the way the capsules work and result from some of the fat being passed out of your body. Such effects typically occur within the first few weeks of using the capsules, before you may have learnt to limit the amount of fat in your diet. Such diet-related treatment effects may be a signal that you have eaten more fat than you should have done.

You can learn to minimise the impact of diet-related treatment effects by following these guidelines:

■ Start your lower-fat diet a few days, or even a week, before you begin taking the capsules.

■ Find out more about how much fat your favourite foods typically contain, and the size of your portions. By familiarising yourself with portions you will be less likely to accidentally exceed your fat target.

■ Distribute your fat allowance evenly across your meals for the day. Do not “save up” fat and calorie allowances and then splurge on a high-fat meal or dessert, as you may have done on other weight loss programmes.

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■ Most users who experience these effects find that they can manage and control them by adjusting their diet.

Do not be concerned if you do not experience any of these problems. This does not mean that the capsules are not working.

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5How to store alli

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How to store alli ■ Keep this medicine out of the sight and reach of children.

■ Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. The expiry date refers to the last day of that month.

■ Do not store above 25°C.

■ Keep the container tightly closed to protect from moisture.

■ The bottle contains two sealed canisters containing silica gel to keep the capsules dry. Keep the canisters in the bottle. Do not swallow them.

■ You can also keep your daily dose of alli in the blue carry case (Shuttle®) included in this pack. Discard any capsules stored in the carry case for more than one month.

■ Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

376Contents of the pack and other information

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Contents of the pack and other information

This chapter contains:

■ What alli contains

■ What alli looks like and contents of the pack

■ Marketing authorisation holder and manufacturer

■ Further helpful information

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Contents of the pack and other informationWhat alli contains

The active substance is orlistat. Each hard capsule contains 60 mg of orlistat.

The other ingredients are: ■ Capsule filling: microcrystalline cellulose (E460), sodium starch

glycolate, povidone (E1201), sodium laurilsulfate, talc. ■ Capsule shell: gelatin, indigo carmine (E132), titanium dioxide

(E171), sodium laurilsulfate, sorbitan monolaurate, black ink (shellac, iron oxide black (E172), propylene glycol).

■ Capsule band: gelatin, polysorbate 80, indigo carmine (E132).

What alli looks like and contents of the pack

alli capsules have a turquoise cap and body, with a dark blue band round the middle, imprinted with “alli”.

alli is available in pack sizes of 42, 60, 84, 90 and 120 capsules. Not all pack sizes may be available in all countries.

A blue carry case (Shuttle®) is included in this pack for carrying your daily dose of alli.

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Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.

Manufacturer: Famar S.A., 48 KM Athens-Lamia, 190 11 Avlona, Greece.

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België/Belgique/BelgienGlaxoSmithKline Consumer Healthcare s.a./n.v. Tél/Tel: + 32 1085 8600

www.alli.be

България ГлаксоСмитКлайн КонсюмърХелткеърTeл.: + 359 2 953 10 34

www.alli.bg

Česká republikaGlaxoSmithKline s.r.o.Tel: + 420 222 001 111gsk.czmail@gsk.com

www.alli.cz

DanmarkGlaxoSmithKline ConsumerHealthcare A/STlf: + 45 80 25 16 27scanda.consumer-relations@gsk.com

www.alliplan.dk

Deutschland GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Tel: 0049 (0) 180 3 63462554

www.alliprogramm.de

Eesti GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk.com

www.alli.gsk.ee

Ελλάδα GlaxoSmithKline A.E.B.E. Λ. Κηφισίας 266, 152 32 ΧαλάνδριΤηλ: + 30 210 68 82 100

www.alli.gr

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

You can also visit your country specific alli website for further information about the alli weight loss programme.

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España GlaxoSmithKline Consumer Healthcare, S.A. Tel: + 34 900 816 705

www.alli.com.es

France GlaxoSmithKline Santé Grand Public Tél.: + 33 (0)1 39 17 80 00

www.alliprogramme.fr

Hrvatska GlaxoSmithKline d.o.o. Tel:+385 1 6051 999

www.alli.com.hr

Ireland GlaxoSmithKline Consumer Healthcare (Ireland) Limited Tel: + 353 (0)1 495 5000

www.alli.ie

Ísland GlaxoSmithKline ehf. Sími: + 354 530 3700

Italia GlaxoSmithKline Consumer Healthcare S.p.A. Tel: +39 02 38062020

www.alli.it

Κύπρος C.A. Papaellinas Ltd, Τ.Θ. 24018, 1700 Λευκωσία Tηλ. +357 22 741 741

www.alli.com.cy

Latvija GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com

www.alli.com.lv

Lietuva GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com

www.alli.lt

Luxembourg/Luxemburg GlaxoSmithKline Consumer Healthcare s.a./n.v. Belgique/Belgien Tél/Tel: + 32 1085 8600

www.alli.be

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Magyarország GlaxoSmithKline Kft. Consumer Healthcare Tel.: + 36 1 225 5800

www.alliprogram.hu

Malta GlaxoSmithKline (Malta) Limited Tel: + 356 21 238131

www.alli.com.mt

Nederland GlaxoSmithKline Consumer Healthcare BV Tel: +31 (0) 30 693 8780 info.nlch@gsk.com

www.alli.nl

Norge GlaxoSmithKline Consumer Healthcare Tlf: + 47 80 05 86 30 scanda.consumer-relations@gsk.com

www.alliplan.no

Österreich GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Tel: 0049 (0) 180 3 63462554

www.alliprogramm.at

Polska GlaxoSmithKline Consumer Healthcare Sp. z o.o. Tel.: + 48 (0)22 576 96 00

www.alli.pl

Portugal GlaxoSmithKline Consumer Healthcare – Produtos para a Saúde e Higiene, Lda. Tel: 800 784 695 apoio.consumidor@gsk.com

www.alli.pt

România GlaxoSmithKline Consumer Healthcare S.R.L. Tel: + 40 21 302 8 208

www.alli.ro

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Slovenija GSK d.o.o., Ljubljana Tel: + 386 (0)1 280 25 00

www.alli.si

Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com

www.alli.sk

Suomi/Finland GlaxoSmithKline Oy Consumer Healthcare Puh/Tel: 080 077 40 80 scanda.consumer-relations@gsk.com

www.alliplan.fi

Sverige GlaxoSmithKline Consumer Healthcare Tel: 020-100579 scanda.consumer-relations@gsk.com

www.alliplan.se

United Kingdom GlaxoSmithKline Consumer Healthcare Tel: + 44 (0)800 171 2014 (Freephone) customer.relations@gsk.com

www.alli.co.uk

This leaflet was last revised in 30 June 2017.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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Further helpful information

Risk of being overweight

Being overweight will affect your health and increase your risk of developing several serious health problems such as:

■ High blood pressure

■ Diabetes

■ Heart disease

■ Stroke

■ Certain forms of cancer

■ Osteoarthritis

Talk to your doctor about your risk of developing these conditions.

Importance of losing weight

Losing weight and maintaining weight loss, for example by improving your diet and increasing your physical activity, can help reduce the risk of serious health problems and help improve your health.

Helpful tips on your diet and your calorie and fat targets while taking alli

alli should be used along with a reduced calorie, lower-fat diet. The capsules work by preventing some of the fat you eat from being absorbed but you can still eat foods from all the main food groups. Although you should focus on the calories and fat that you eat, it is important to eat a balanced diet. You should choose meals which contain a range of different nutrients and learn to eat healthily for the long term.

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Understanding the importance of calorie and fat targetsCalories are a measurement of the energy your body needs. They are sometimes called kilocalories or kcal. Energy may also be measured in kilojoules, which you may also see on food labels.

■ The calorie target is the maximum number of calories you will eat each day. See the chart further on in this section.

■ Your fat gram target is the maximum number of grams of fat you will eat in each meal. The fat gram target chart follows the information below on setting your calorie target.

■ Controlling your fat target is essential because of the way the capsules work. Taking alli means your body will pass more fat through, and therefore may struggle to cope with eating as much fat as before. So by meeting your fat target, you will maximise weight loss results while minimising the risk of diet-related treatment effects.

■ You should aim to lose weight gradually and steadily. Losing around 0.5 kg (1 lb) per week is ideal.

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How to set your calorie target

The following table has been worked out so that it gives you a calorie target that is about 500 calories fewer per day than your body needs to maintain your current weight. That adds up to 3500 fewer calories per week, about the number of calories in 0.5 kg (1 lb) of fat.

Your calorie target alone should allow you to lose weight at a gradual, steady pace of about 0.5 kg (1 lb) per week, without feeling frustrated or deprived.

Eating fewer than 1200 calories per day is not recommended.

You will need to know your activity level to set your calorie targets. The more active you are, the higher your calorie target.

■ Low activity means you do little or no walking, climbing stairs, gardening, or other physical activity on a daily basis.

■ Moderate activity means you burn around 150 calories per day in physical activity, for example, walking three kilometres (2 miles), gardening for 30 to 45 minutes, or running two kilometres (1.25 miles) in 15 minutes. Choose the level that most closely fits your daily routine. If you are unsure which level you are, choose Low activity.

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Women

Lowactivity

Below 68.1 kg

68.1 kg to 74.7 kg

74.8 kg to 83.9 kg

84.0 kg and over

Below 10 st 10 lb

10 st 10 lb to 11 st 11 lb

11 st 12 lb to 13 st 2 lb

13 st 3 lb and over

1200 calories

1400 calories

1600 calories

1800 calories

Moderateactivity

Below 61.2 kg

61.3 kg to 65.7 kg

65.8 kg and over

Below 9 st 9 lb

9 st 9 lb to 10 st 4 lb

10 st 5 lb and over

1400 calories

1600 calories

1800 calories

Men

Lowactivity

Below 65.7 kg

65.8 kg to 70.2 kg

70.3 kg and over

Below 10 st 4 lb

10 st 5 lb to 11 st

11 st 1 lb and over

1400 calories

1600 calories

1800 calories

Moderateactivity

59.0 kg and over 9 st 4 lb and over 1800 calories

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How to set your fat target

The following chart shows how to set your fat target based on the amount of calories you are allowed per day. You should plan to have three meals per day. If you have set a target of 1400 calories per day, for example, the maximum amount of fat allowed per meal would be 15 g. To stay within your daily allowance for fat, snacks should contain no more than 3 g of fat.

Maximum amount of fat allowed per meal

12 g

15 g

17 g

19 g

Maximum amount of fat allowed from

snacks per day

3 g

3 g

3 g

3 g

Amount of calories you can eat per day

1200

1400

1600

1800